In this paper, barcode technique is combined with laboratory information system to improve the degree of automation in laboratory. Barcode stuck to specimen collected, such routine laboratory operations are finished according to barcode as specimen sorting, data transmission, two-way communication of analyzing machine, results verifying, reports inquiring, specimen keeping et al. As the only specimen identification, barcode is used to realize two-way communication between analyzing machine and it, thus laboratory workflow is simplified. The application of barcode technique to clinical laboratory improves work efficiency, result reliability and degree of automation greatly. It is the development direction in laboratory in the future.

Objective:To construct inhibin expression vector with high immunogenicity.Methods:S gene with enzyme site sequence of EcoR I and Nde I was amplified by PCR from pCMV-S;Inhibin(1-32)gene with enzyme site sequence of Nde I and Hind III was cut from pUI;S and inhibin(1-32)gene were directly inserted into pcDNA3.1(-)and the recombinant pCIS was identified by restriction endonculease digestion and sequencing;then pCIS was transfected into HeLa cells.SDS-PAGE and ELISA was employed to detect the cell product.Rats were immunized with inhibin fused expression plasmid pCIS and ELISA was used to detect the blood antibody against inhibin.Results:The recombinant eukaryocyte expression vector of inhibin was constructed.The sequence of the insert was identical to designed gene.Fusion protein weight was about 29 kD and it had inhibin immunologic activity.Rats immunized with pCIS induced antibody against inhibin.Conclusion:The fusion gene expression vector was successfully constructed,and it set up the basis of inhibin gene immunization to induce multiple bear for single birth animals.

Objective To explore the clinical users′experience on using the intelligent laboratory test system so as to provide reference for its optimization.Methods Fifteen laboratory staff with different sub specialty was selected for in-depth interviews and data were analyzed using phenomenological approach.Results Intelligent laboratory system could improve the quality of test result verification and interpretation,shorten the turnaround time and improve the work efficiency.It took about 1-2 months for users to accept the automatic verification function.After that,the users could believe in the system and used it in their daily work.The sys-tem could reduce the work stress and verification duty,while balancing the technical gap between laboratory technicians.Users could only understand the general rule of the intelligent system and it was difficult for them to manage the rule repository.Conclu-sion The intelligent laboratory system is one of the artificial intelligent system used for the medical laboratory,it can provide com-prehensive clinical decision support for the laboratory staff.

The medical consulting service, disease inquiry and seeking medical advice functions of 10 commonly available APP software in China for seeking medical advice, such asRapid Asking Doctors,Handholding Doc-tor Selection, andChunyu Handholding Doctors, were compared, which showed that although the functions of APP software in China for seeking medical advice could meet the requirement of people for seeking medical advice, importance should be further attached to their accurate and integrative information and establishment of profit-making model in order to promote the sustainable development of medical APP software.

Objective Analyze the historical data of critical values lists,providing scientific evidence for continuous improvement of critical value systems.Methods Screen out critical value lists data of 2006 from laboratory information system,after pretreatment and transformation of data,calculate the percentage of critical value,and its daily distribution,weekly distribution and department distribution, evaluate the range and turnaround time for critical value.Results The rate of critical value was 1.67%.It was mainly concentrated from 8 to 13 O'clock.Monday and Thursday have more critical value than other days.From the perspective of department,the majority critical value was from hematology department and transplantation department.After the evaluation of distribution diagram of critical value range,the lower critical value limit of blood potassium was adjusted from 3.0 mmol/L to 2.8 mmol/L,the blood platelet and leukocyte counts for parlents with hematology disease were a(Ijusted from 20×109/L,1.5×109/L to 10×1O9/L,1.0×109/L respectively.The laboratory turnaround time for 76.2% critical value was less than 1 hour.Conclusion Review and analyze critical value lists data regularly can improve the work efficiency and quality for the laboratory and clinic department and better meet patients' safety needs.

Objective To investigate the clinical application of VCS parameters of leukocyte in the detection of blood bacterial infection, Methods The subjects consisted of 120 patients with blood bacterial infection,69 non-infectious fever patients and 67 health controls.The VCS parameters of neutrophil and lymphocyte were examined with Coulter LH 750 hematology analyzer.The parameters examined including mean channel of neutrophil volume(MNV),neutrophil volume distribution width (NDW) ,mean channel of neutrophil conductivity (MNC),mean channel of neutrophil scatter (MNS),mean channel of lymphocyte volme(MLV),lymphocyte volume distfibufion width (LDW),mean channel of lymphocyte conductivity (MLC) and mean channel of lymphocyte scatter (MLS).Additionally,120 blood bacterial infection patients were grouped according to WBC count(WBC≤10×109/L group and WBC＞10×109/L group),neutrophii rate(≥85%group and＜85%group)and bacterial stain(Gram positive bacteria group and Gram negative bacteria group).VCS parameters among these groups were compared.Results The results of blood infection group were as follows:MNV 156±15,NDW 23.31±3.72,MNS 137±7,MLV 87±12,LDW 17.50±3.38.MLC 110±5 and MLS 69±12.The results of non-infectious fever group were as follows:MNV 151±8,NDW 21.33 ±2.62,MNS 132±10,MLV 91±4.LDW 15.78±1.96.MLC 117±4 and MLS 62±6.The results of control group were as follows:MNV145 ±5.NDW 18.43±0.93.MNS 143 ±4,MLV 84±2,LDW 13.30±0.76.MLC 108±1 and MLS 62±2.There were significant diffierences among these three groups (F value were 19.295,26.272,32.767,6.226,31.016,23.739 and 12.662 respectively,P＜0.05 or P＜0.01).In the infection group.the MNV and NDW were 152 ±16 and 22.19±3.45 respectively for WBC≤10×109/L group.159±12 and 25.29±3.43 respectively for WBC＞10×109/L group.They were both significantly different compared with control group (F valRe were 21.575 and 40.856 respectively,P＜0.01).Also in the infection group.the MNV and NDW were 159±12 and 24.88 ±3.74 respectively for neutrophil rate≥85%group.151±16 and 21.68±2.29 respectively for neutrophil rate＜85%group.They were both significantly different compared with control group(F value were 23.76 and 43.22 respectively,P＜0.01).The MNV and NDW were 157±15 and 24.25±3.39 respectively in those cases with gram-negative bacteremia,153±14 and 21.51±3.78 respectively in those cases with gram-positive bacteremia.They were both signifieanfly difierent compared with control group (F value were 18.74 and 37.47 respectively,P＜0.01).With a cut-off value of 20.50 for the NDW,a sensitivity of 76.7%and specificity of 98.3% were achieyed in diagnosing blood hacterial infection.Conclusion The VCS parameters can reflect the morphologic change of leukocyte in blood bacterial infection.Additionally.the NDW can detect blood bacterial infection more sensitively and specifically.

Objective To analyze the detection rate of HBV serological makers in non-hepatic inpatients in the past six years. Methods Serum samples of 70 582 non-hepatic inpatients from three large hospitals were collected during 2003 to 2008. Serological markers of HBV ( HBsAg, anti-HBs, HBeAg, antiHBe and anti-HBc) were detected by the AxSYM MEIA system (Abbott Laboratories,Abbott Park,IL).Combining the test results of serological makers with other clinical data, several analysis models for this retrospective study were set up to evaluate the year-to-year changes in serological makers and the detection rates of each model. Results The order from high to low of detection rate of the 5 HBV serological markers was anti-HBc (55. 17% ), anti-HBs (49. 57% ), anti-HBe (28.42%), HBsAg ( 8. 92% ) and HBeAg (2. 12% ), and all of them had a downward trend in the past six years. The positive rate of HBsAg went down from 9. 30% (2003) to 8.70% (2008). The positive rate of HBsAg among people who were born after 1992 (2. 28% ) were significantly lower than that of the overall population (8. 92% ) and fell from 3.57%(2003) to 1.85% (2008). Each detection rate of all serological makers had male sexual side effect [HBsAg ( 12. 38%/7. 25% ), HBeAg ( 2. 72%/1.58% ), anti-HBc ( 56. 57%/53.43% ), anti-HBe (41.50%/28. 35% ) and anti-HBs (65.48%/50. 00% ), male/female]. The differences were statistically significant (Chi-square values of HBsAg, HBeAg, anti-HBc, anti-HBe and anti-HBs were 509.74,105.78, 69.66, 1 321.61 and 1 726.91, respectively; all P ＜ 0. 01).Twenty-six models of HBV serological makers from 70 582 inpatients were summed up, and 8 models had positive rates geater than or equal to 1%. The "All Negative" model ranked No. 1 and had no significant change from year to year. During the past six years, models representing "A11 Negative" and "anti-HBs Positive alone" were mainly in individuals younger than or equal to 20-year-old, while the models representing "anti-HBc and/or anti-HBe,anti-HBs Positive" were mostly in people older than 20-year-old. The distribution curve of models representing "HBsAg, HbeAg and anti-HBc Positive" and "HBsAg, anti-HBc, anti-HBe Positive"etc. showed a bell-shape, covering the population from 20-year-old to 70-year-old. Conclusions The slowlydescending tendency of the detection rates of HBV serological makers was observed during the past six years.The detection rates of HBV in the younger generation decreased significantly. However, the HBV infection rates of overall population is still high, so it is a high time that we made continuous improvement for the serum HBV screening technique in order to reduce the HBV infection ratess.

Objective To investigate the prevalence and trends of human papillomavirus (HPV)infections in gynecology outpatients in Zhejiang province.Methods Samples of cervical exfoliated cells were collected from gynecology outpatients in 11 sentinel hospitals in Zhejiang Province from January 2011 to December 2013.Twenty one HPV subtypes were detected by flow-through hybridization technique.Chisquare test was performed to analyze the prevalence rates of HPV infections in different years and in different age groups.Results A total of 14 569 patients were enrolled in the study,among whom 3 552 (24.38％)were positive for HPV.HPV-16 (5.77％,840/14 569),HPV-52 (4.71％,686/14 569) and HPV-58 (4.52％,659/14 569) were the most prevalent subtypes.Among all patients,2 244 (15.40％) were infected with a single high-risk subtype,426 (2.92％) were infected with a single low-risk subtype,and 882 (6.05％) were infected with multiple subtypes.The rate of multiple infection was on the rise during 2011 and 2013 (x2 =23.65,P ＜0.01).The positive rates of HPV in patients with 15-24 y age group and ＞54 y age group were 27.91％ (211/756) and 27.73％ (439/1 583) respectively,which were higher than those in other age groups (x2 =18.664,P ＜ 0.01).Conclusion HPV infection is popular in gynecology outpatients in Zhejiang province,especially in patients aged 15-24 y and ＞ 54 y,and a certain proportion of patients are infected with multiple subtypes.

BACKGROUND: Several latest guidelines and consensus statements from Europe and the United States specify that there is no need for fasting prior to routine lipid tests. However, the latest Chinese guidelines still recommend fasting tests owing to a lack of local evidence. This study aimed to investigate postprandial lipid concentrations and daytime biological variation of lipids in a healthy Chinese population. METHODS: Venous blood samples were collected from 41 ostensibly healthy Chinese volunteers at five time points during the day (06:30, 09:00, 12:00, 15:00, and 18:30). The same batch of reagents was used to determine lipid concentrations. A nested ANOVA was performed to calculate within-subject biological variation (CVI) and between-subject biological variation (CVG). RESULTS: Postprandial concentrations of triglyceride were higher than fasting concentrations, with the maximum change occurring at 12:00 (0.5 hours after lunch, 0.21±0.65 mmol/L difference). The daytime biological variation of triglycerides was relatively high (CVI=25%, CVG=35.9%). The postprandial concentrations of total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, apolipoprotein A1, and apolipoprotein B were mostly lower than the fasting concentrations, and their daytime biological variations were relatively low (CVI=2.4–4.4%, CVG=11.8–18.7%). CONCLUSIONS: As most daytime lipid concentrations changed only slightly, non-fasting samples could be used for routine lipid tests. However, in cases of abnormal postprandial triglyceride concentrations, dietary factors and fasting time should be considered when interpreting the results.
Apolipoprotein A-I ; Apolipoproteins ; Asian Continental Ancestry Group* ; Cholesterol ; Consensus ; Europe ; Fasting ; Humans ; Indicators and Reagents ; Lipoproteins ; Lunch ; Triglycerides ; United States ; Volunteers

Objective To analyze nonconformities between 2012 and 2022 version of ISO 15189,and provide strategies of transitioning to new standard for laboratories.Methods A total of 522 nonconformities from 32 on-site audits in 24 laboratories against ISO 15189:2012 were collected and mapped them to the relevant clauses of ISO 15189:2022.Strategies for transitioning ISO 15189 to new version were explored based on the standard requirements,literature review and current laboratory practices.Results On average,16 noncon-formities(range from 8 to 31)were identified in every on-site audit.Most of them were related to ISO 15189:2022 clauses 7.3 Exami-nation Processes(165 nonconformities).The others were clause 6.5 Equipment Calibration and Metrological Traceability(43)and clause 6.6 Reagents and Consumables(40).Relatively fewer nonconformities involved new/enhanced requirements,such as risk man-agement,patient-related processes and point-of-care testing.Conclusion The main nonconformities in ISO 15189:2022 predominantly involved in the link of examination processes.It should be suggested that the laboratories strengthen the management in this area by a-dopting digital/intelligent technologies in order to smoothly implement the requirements of the new version of ISO 15189:2022 standard.A comprehensive strategy,including incorporating training,gap analysis,document revision,implementation involved in all staff,stringent risk management and continuous improvement should be recommended to ensure successful transition progress for replacement of ISO 15189:2022.